BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALAXY G3 MINI 2MM X 4CM

    MDR report key: 10213030 · Received June 30, 2020

    Report

    Report Number
    3008114965-2020-00243
    Event Type
    Malfunction
    Date Received
    June 30, 2020
    Date of Event
    June 12, 2020
    Report Date
    June 12, 2020
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704080305
    PMA / PMN Number
    K171862
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THAT THE PRODUCT WAS RECEIVED BY THE LAB ON 07/13/2020, AND ADDITIONAL EVENT INFORMATION WAS RECEIVED 07/28/2020. THE RETURNED PRODUCT UNDERWENT EVALUATION AND ANALYSIS. E.1: THE INITIAL REPORTER PHONE: (B)(6). [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE OF AN ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM WITH SUBARACHNOID HEMORRHAGE (SAH), THE 2.00MM X 4.00CM GALAXY G3 MINI COIL (GLM920040 / L14628) WAS THE FIRST COIL DELIVERED AND IMPLANTED IN THE TARGET LESION AS INTENDED, HOWEVER, THE PHYSICIAN WAS NOT ABLE TO DETACH THE COIL. THE COIL WAS SAFELY AND SUCCESSFULLY REMOVED FROM THE PATIENT AND REPLACED WITH A COMPETITOR COIL TO CONTINUE WITH THE PROCEDURE TO COMPLETION. IT WAS REPORTED THAT THE POWER LAMP ON THE ENPOWER CONTROL CABLE (ECB00018200 / K10144) ILLUMINATED DURING THE PRE-DEPLOYMENT ELECTRICAL CHECK AND ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT APPLICATION OF EXCESSIVE FORCE. THE EVENT DID NOT RESULT IN ANY PROCEDURAL DELAY OR PROLONGATION. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. THE DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. THE INVESTIGATIONAL FINDING IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: THE NON-STERILE 2.00MM X 4.00CM GALAXY G3 MINI COIL WAS RETURNED CONTAINED IN A POUCH. VISUAL INSPECTION WAS PERFORMED. THE DEVICE POSITIONING UNIT (DPU) WAS OBSERVED KINKED IN SEVERAL AREAS. THE INTRODUCER HAS RESIDUES OF DRIED BLOOD INSIDE. THE MARKER BAND WAS OBSERVED AT 39CM FROM THE HUB; THIS IS WITHIN SPECIFICATION. MICROSCOPIC INSPECTION WAS PERFORMED. THE EMBOLIC COIL WAS OBSERVED DETACHED INSIDE THE MICROCATHETER WITH DRIED BLOOD RESIDUES OBSERVED ON IT. THE RESISTANCE HEATING (RH) COIL SHOWED EVIDENCE OF BEING HEATED AT THIS AREA WITH A FIBER HOOKING CONDITION NOTED. THERE WAS NO OTHER ADDITIONAL DAMAGE OR ANOMALY OBSERVED. FUNCTIONAL EVALUATION: THE RESISTANCE OF THE 2.00MM X 4.00CM GALAXY G3 MINI COIL WAS MEASURED USING A MULTIMETER. THE RESISTANCE WAS MEASURED TO BE 51.4O; THIS IS WITHIN THE SPECIFICATION RANGE OF 48.5 O ¿ 56.0 O. THE DEVICE WAS THEN CONNECTED TO A DETACHMENT CONTROL BOX (DBC2000500) USING A LAB SAMPLE ENPOWER CONTROL CABLE AND THE POWER WAS TURNED ON. THE SYSTEM READY LIGHT BECAME ILLUMINATED. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (L14628) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. THE COMPLAINT DOCUMENTED THAT DURING THE PROCEDURE, THE 2.00MM X 4.00CM GALAXY G3 MINI COIL WAS THE FIRST COIL DELIVERED AND IMPLANTED IN THE TARGET LESION, HOWEVER, THE PHYSICIAN WAS NOT ABLE TO DETACH THE COIL. THE COIL WAS SAFELY REMOVED FROM THE PATIENT AND REPLACED WITH A COMPETITOR COIL TO COMPLETE THE PROCEDURE. THE DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. THE DPU WAS KINKED IN SEVERAL AREAS, THE EMBOLIC COIL WAS DETACHED INSIDE THE MICROCATHETER WITH NOTED RESIDUES OF DRIED BLOOD OBSERVED. THE RH COIL SHOWED EVIDENCE THAT IT WAS HEATED. THE ISSUE REPORTED THAT THE COIL FAILED TO DETACH COULD NOT BE DUPLICATED; THE COIL WAS ALREADY IN A DETACHED STATE. PRIOR TO UNDERGOING FUNCTIONAL ANALYSIS, THE RESISTANCE OF THE DEVICE WAS CHECKED AND WAS FOUND TO BE WITHIN SPECIFICATION. WHEN CONNECTED TO THE LAB DCB AND LAB SAMPLE ENPOWER CONTROL CABLE, THE SYSTEM READY LIGHT ILLUMINATED WHEN THE POWER WAS TURNED ON. THE OBSERVED RESIDUES OF DRIED BLOOD INSIDE THE INTRODUCER ON THE DETACHED COIL SUGGEST THAT FLUSH HAVE BEEN INSUFFICIENTLY MAINTAINED THROUGH THE MICROCATHETER DURING THE PROCEDURE. THE KINKED AREAS ON THE DPU ARE LIKELY DUE TO INADVERTENT FORCE APPLIED ON THE DEVICE DURING PROCEDURAL HANDLING. BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. DEVICES UNDERGO 100% INSPECTION AT FINAL ASSEMBLY FOR THE CONDITION OF THE EMBOLIC COIL. THUS, IT IS NOT LIKELY THAT THE 2.00MM X 4.00CM GALAXY G3 MINI COIL LEFT THE MANUFACTURING FACILITY WITH ANOMALIES ON THE EMBOLIC COIL AND THE DPU. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE/PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, GENDER, WEIGHT, RACE, ETHNICITY, AND MEDICAL HISTORY WERE NOT PROVIDED. PROCODE IS KRD/HCG. THE NAME, PHONE AND EMAIL ADDRESS OF THE INITIAL REPORTER ARE NOT AVAILABLE / REPORTED. (B)(6). THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION AND TESTING. HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE AS INDICATED AS ¿OTHER¿ IN THIS SECTION AS THE REASON FOR NON-EVALUATION. IF THE DEVICE RETURNS, A DEVICE INVESTIGATION WILL BE PERFORMED. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (L14628) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE OF AN ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM WITH SUBARACHNOID HEMORRHAGE (SAH), THE 2.00MM X 4.00CM GALAXY G3 MINI COIL (GLM920040 / L14628) WAS THE FIRST COIL DELIVERED AND IMPLANTED IN THE TARGET LESION AS INTENDED, HOWEVER, THE PHYSICIAN WAS NOT ABLE TO DETACH THE COIL. THE COIL WAS SAFELY REMOVED FROM THE PATIENT AND REPLACED WITH A COMPETITOR COIL TO CONTINUE WITH THE PROCEDURE TO COMPLETION. IT WAS REPORTED THAT THE POWER LAMP ON THE ENPOWER CONTROL CABLE ILLUMINATED DURING THE PRE-DEPLOYMENT ELECTRICAL CHECK. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677077 GALAXY G3 MINI 2MM X 4CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL GLM920040 L14628 10886704080305

    Patients

    Seq Age Sex Outcome Treatment
    1 ENPOWER CONTROL CABLE